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This position is responsible for quality control (QC) review of clinical documents intended for submission to health authorities worldwide. The Senior Clinical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with company SOPs and processes to ensure documents meet required standards, and may oversee the workload for the editors, establishing schedules and interacting with cross-functional authors. The Senior Clinical Editor performs the activities with minimal oversight needed.

Essential Functions of the Job (Key responsibilities)

• Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents) to ensure compliance with the Incyte Style Guide and submission standards.

• Verify data in documents against the source tables, figures, and listings and format tables according to Incyte standards.

• Copyedit/proofread clinical documents for grammar, style, and formatting according to AMA and Incyte style guides.

• Ensure internal consistency and confirm that data are reported correctly, statements accurately reflect source documents or data (eg, SAS tables and listings).

• Check reference list in documents, including verifying citation information vs PubMed, ordering copies of references and adding to the electronic document management system (EDMS), and ensuring each reference is cross-referenced in the document.

• Proofread documents against the standard templates to ensure compliance with required sections and text.

• Perform publishing of nonclinical and clinical documents and the compilation of required CSR appendices, as needed.

• Lead and actively participate in process improvement initiatives and assist Medical Writing staff with other tasks, as appropriate.

• May oversee the workload for the editors, establishing schedules and interacting with cross-functional authors.

• Assist with training of more junior editors or contract staff.

• Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor’s degree in English, Basic Science, Business, or other analytical field with 4 years related experience in the pharmaceutical industry OR 8+ years of experience in a discipline directly related to document production (eg, medical writing, QC, editing, publishing).

• Strong working knowledge of the editorial and publishing activities within Clinical Development.

• Proficient in Microsoft Word, including the ability to format tables, insert cross-references, apply styles, and use templates. Experience with PowerPoint, Excel, Visio, Adobe.

• Strong working knowledge of Adobe PDF bookmarking and internal/external hyperlinking to meet submission-ready standards.

• Experience in the use of an EDMS (eg, Veeva Vault or SharePoint).

• Ability to effectively communicate with vendors and manage outsourced editorial work.

• Keen attention to detail.

• Ability to manage multiple activities, prioritize effectively, and work in a fast-paced, deadline-driven environment.

• Strong organizational and time management skills.

• Strong verbal, written, and interpersonal communication skills.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $97,700.00 - $162,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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